The Efficacy of Platelet Rich Plasma Compared with Corticosteroid Injections for the Treatment of Pain Associated with Hip Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Pain Score VAS
研究概览
简要总结
Prospective, single-center that may go on to being multicenter, randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of Hip osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.
详细描述
Platelet rich plasma has become increasingly utilized as a treatment option for Hip osteoarthritis. Corticosteroids is currently an approved medication to treat the symptoms of the Hip osteoarthritis. There is limited evidence in a prospective randomized manner powered adequately to determine a difference between these treatments for pain associated with Hip osteoarthritis.
Prospective, single center that may go on to be multi-center, single blind (participant), randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of Hip osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Given the nature of this study, blinding will not be possible for the treating surgeon and research staff. The participants will be blinded from the regimen that they receive, and both groups will have blood drawn and the injection will be covered in a manner to ensure participants cannot ascertain the treatment regimen.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 21-80 years
- •Radiographic diagnosis of Kellgren-Lawrence (KL) grade of II or III Hip osteoarthritis
- •Indicated for a Hip injection to treat Hip OA symptoms
排除标准
- •Any injections into the target Hip within three months
- •Current overlying skin infection
- •Current or previous diagnosis of "chronic pain"
- •Opioid tolerant at time of screening (for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.)
- •Allergy to any potential ingredients or medications utilized in any of the two groups
- •Treatment with another investigational drug or other intervention for pain
- •Diagnosis of Diabetes Mellitus
- •If female, pregnant or planning to be pregnant within the following 3 months or study duration
- •Any condition(s) or diagnosis, both physical or psychological, or physical exam finding in the opinion of the investigator that would precludes participation
研究组 & 干预措施
Autologous Platelet Rich Plasma
~Injection of approximately 10 mL autologous PRP Magellan Autologous Concentration System, ISTO Biologics
干预措施: Platelet Rich Plasma Joint Injection (Device)
Corticosteroid
5 milliliters (mL) injection of corticosteroid (1cc Kenalog, 4cc Xylocaine) Kenalog - 40 (triamcinolone acetonide injectable suspension, USP) Xylocaine - MPF (lidocaine HCl Injection, USP)
干预措施: Corticosteroid Injection (Drug)
结局指标
主要结局
Pain Score VAS
时间窗: baseline, six weeks, and three months
Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Pain intensity that is calculated by measuring the distance from the "no pain" end of a line to a mark placed by the patient to indicate their current pain level. This will be measured at baseline, six weeks, and three months.
次要结局
- Pain Score NRS(baseline, six weeks, and three months.)
- Functional score HOOS(baseline, six weeks, and three months)
- Functional score HHS(baseline, six weeks, and three months)
- Functional score WOMAC(baseline, six weeks, and three months)
- Pain Medication Adherence(Baseline through three months)